Medline Industries, LP: Medline Convenience Kits: 1) CVC PACK, Model Number: CVI4500A; 2) TOTE KAMAL OSC HAND REPAIR, Model Number: DYKM1730A; 3) TOTE CHANGE OSC HAND REPAIR, Model Number: DYKM1751A;

Hazard

Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products.

Details from the source

Reason for recall: Medline has identified issues related to calibration of the equipment used to sterilize and package the devices. All products were exposed to the validated sterilization and packaging cycles; however, the identified calibration issues have the potential to impact the sterility assurance level (SAL) of the Recalled Products. Distribution: Worldwide - US Nationwide distribution. Quantity: 1516 units Lot/code info: 1) CVI4500A, UDI-DI: 10653160327646(each), 653160327649(case), Lot Number: 2020121550; 2) DYKM1730A, UDI-DI: 10193489111019(each), 20193489111016(case), Lot Number: 2024030690; 3) DYKM1730A, UDI-DI: 10193489111019(each), 20193489111016(case), Lot Number: 2024052290; 4) DYKM1730A, UDI-DI: 10193489111019(each), 20193489111016(case), Lot Number: 2024060590; 5) DYKM1730A, UDI-DI: 10193489111019(each), 20193489111016(case), Lot Number: 2025012890; 6) DYKM1751A, UDI-DI: 10193489111002(each), 20193489111009(case), Lot Number: 2023121190; 7) DYKM1756A, UDI-DI: 10193489190250(each), 20193489190257(case), Lot Number: 2023060290; 8) DYKM1756A, UDI-DI: 10193489190250(each), 20193489190257(case), Lot Number: 2023070590; 9) DYKM1756A, UDI-DI: 10193489190250(each), 20193489190257(case), Lot Number: 2023111590; 10) DYKM1756A, UDI-DI: 10193489190250(each), 20193489190257(case), Lot Number: 2023120590; 11) DYKM1756A, UDI-DI: 10193489190250(each), 20193489190257(case), Lot Number: 2024022190; 12) DYKM1756A, UDI-DI: 10193489190250(each), 20193489190257(case), Lot Number: 2024080190; 13) DYKM1756A, UDI-DI: 10193489190250(each), 20193489190257(case), Lot Number: 2024101490; 14) DYKM1765A, UDI-DI: 10193489190236(each), 20193489190233(case), Lot Number: 2023050490; 15) DYKM1765A, UDI-DI: 10193489190236(each), 20193489190233(case), Lot Number: 2023071290; 16) DYKM1765A, UDI-DI: 10193489190236(each), 20193489190233(case), Lot Number: 2024012490; 17) DYKM1765A, UDI-DI: 10193489190236(each), 20193489190

UPC codes

10653160327646, 653160327649, 10193489111019, 20193489111016, 10193489111002, 20193489111009, 10193489190250, 20193489190257, 10193489190236, 20193489190233, 10193489112368, 20193489112365, 10888277733794, 20888277733791, 10653160352730, 653160352733, 10193489111330, 20193489111337, 10653160354888, 653160354881, 10653160360421, 653160360424, 10193489191219, 20193489191216, 10193489191257, 20193489191254, 10193489190311, 20193489190318, 10193489199901, 20193489199908, 10653160360797, 653160360790, 10195327058715, 40195327058716

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.